Zebinix non-inferior to current standard of care in epilepsy

Eisai and Bial’s epilepsy drug Zebinix has shown effectiveness on par with that of the current standard of care in newly diagnosed focal epilepsy patients.

A Phase III study assessing once-daily Zebinix (eslicarbazepine acetate) as a monotherapy demonstrated that it is non-inferior compared to twice-daily controlled-release carbamazepine.

According to the data, published in the journal Epilepsia, 71.1 percent of patients on Zebinix and 75.6 percent of those on controlled-release carbamazepine were seizure-free for six months or more, while for one year the figures were 64.7 percent 70.3 percent, respectively.

Also, although adverse event rates were similar in the two treatment groups, Zebinix had lower rates of discontinuation due to adverse events than carbamazepine, the firms noted.

“For this patient population in particular, it is important that the physician takes into consideration individual factors and tailors treatment to the individual. We therefore welcome the news that another treatment has been shown to be effective for these patients, especially one with an easy to use once-daily formulation that has the potential to improve adherence,” said Eugen Trinka, lead author of the study, Professor and Chair, Department of Neurology, and medical director Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.

Zebinix is a voltage-gated sodium channel blocker, which selectively targets the slow inactivated state of the sodium ion channel.

The drug is first approved in Europe in 2009 as adjunctive therapy in adults, adolescents and children aged above six years, with partial-onset seizures with or without secondary generalization, and in 2017 as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy.

Epilepsy is one of the most common neurological conditions in the world, affecting approximately fifty million people in Europe.